Evaluation of Dual-hormone Artificial Pancreas With Closed-loop Glucose Control Versus Single-hormone With Carbohydrate Recommendations Under Unannounced Exercise and Meal Challenge in Adults With Type 1 Diabetes.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Number of Level 1 (<70 mg/dL) and Level 2 (<54 mg/dL) hypoglycemic events
研究概览
简要总结
The present clinical trial aims to examine alternative strategies for preventing/mitigating hypoglycemic events among adults with type 1 diabetes utilizing a highly personalized control system. This system offers two configurable options: a single-hormone configuration with automatic rescue carbohydrate recommendations (sHC) and a dual-hormone configuration with subcutaneously administered glucagon boluses (dHmG). The main question addressed in this study focuses on determining whether the dHmG outperforms the sHC in terms of minimizing the time spent below the target range and number of hypoglycemic events.
Each participant will undergo two 12-hour controlled inpatient studies, including each an unannounced 30-min aerobic exercise session and a meal challenge. The order of these studies, comparing the dHmG to the sHC, will be randomized.
详细描述
RATIONALE OF THE STUDY
Automated insulin delivery (AID), commonly referred to as artificial pancreas, represents the most advanced treatment for individuals with type 1 diabetes (T1D). AID is recognized for its ability to optimize insulin treatment, thereby maximizing the time spent within the target range (TIR) while minimizing instances of blood glucose levels falling below or exceeding the target range. At present, several hybrid AID systems are commercially available, primarily in the EU and US, providing this population with the benefits of this advanced therapy. Despite the benefits offered by current AID systems and diabetes technology in general for the treatment of T1D, only approximately 20% of individuals achieve the recommended glycemic target. The existing systems heavily rely on timely and accurate information from the user regarding two significant glycemic disturbances: meals and physical activity. Overestimation of carbohydrate intake and physical activity are the primary drivers contributing to postprandial and episodic hypoglycemia, respectively, with potential consequences during the overnight period.
The current investigation aims to examine alternative strategies for preventing/mitigating hypoglycemic events utilizing a highly personalized control system. This system offers two configurable options: a single-hormone configuration with automatic rescue carbohydrate recommendations and a dual-hormone configuration with subcutaneously administered glucagon boluses. The research question addressed in this study focuses on determining whether the dual-hormone configuration outperforms the single-hormone with rescue carbohydrate recommendations configuration in terms of minimizing the time spent below the target range.
HYPOTHESIS
Our hypothesis suggests that the utilization of the dual-hormone configuration will result in a decrease in the amount of time spent below the target range (70-180 mg/dL) and a reduction in the number of hypoglycemic events in comparison to the single- hormone configuration with automatic rescue carbohydrate recommendations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 65 years.
- •CSII treatment for a minimum of 6 months prior to Visit
- •Body mass index between 18 and 30 kg/m
- •HbA1c level below 9.0% at Visit
- •Physical examination, laboratory data, and ECG (electrocardiogram) results are within normal limits. Clinically insignificant abnormalities, as determined by the investigator, will not be considered
排除标准
- •Postmenopausal women or women of childbearing age who have a negative urine pregnancy test during the screening visit.
- •Exclusion Criteria:
- •Pregnancy or breastfeeding.
- •Hypoglycemia unawareness (as indicated by a Clarke Test score greater than 3).
- •Presence of progressive, fatal disease.
- •History of drug or alcohol abuse.
- •History of being HIV positive, active hepatitis B or hepatitis C.
- •Impaired liver function, as evidenced by serum glutamic-pyruvic transaminase (SGPT) or serum glutamic-oxaloacetic transaminase (SGOT) levels exceeding twice the upper limit of the reference normal range at Visit
- •Clinically significant microvascular complications (such as macroalbuminuria, pre-proliferative and proliferative retinopathy), cardiovascular, hepatic, neurological, endocrine, or other systemic conditions, apart from T1D, that may hinder the implementation of the clinical study protocol or the interpretation of study results.
- •Scheduled surgery during the study period.
- •Mental conditions that affect the subject's ability to comprehend the nature, purpose, and potential consequences of the study.
- •Subjects deemed unlikely to adhere to the clinical study protocol, including those with an uncooperative attitude, inability to attend follow-up visits or low likelihood of completing the study.
- •Use of an experimental drug or device within the past 30 days.
结局指标
主要结局
Number of Level 1 (<70 mg/dL) and Level 2 (<54 mg/dL) hypoglycemic events
时间窗: 12-hour inpatient study
Occurrence of hypoglycemic events during at least 15 min
% time below range (<70 mg/dL)
时间窗: 12-hour inpatient study
Percentage of time spent below the target range
次要结局
- Coefficient of variation (CV) of CGM values(12-hour inpatient study)
- Total glucagon(12-hour inpatient study)
- %time in range (70-180 mg/dL)(12-hour inpatient study)
- %time >180 mg/dL(12-hour inpatient study)
- Average glucose(12-hour inpatient study)
- Standard deviation(12-hour inpatient study)
- Time with glucose levels <3.0 mmol/l (54 mg/dl)(12-hour inpatient study)
- %time > 250 mg/dL(12-hour inpatient study)
- Total insulin(12-hour inpatient study)
- %time in range (70-140 mg/dL)(12-hour inpatient study)
- Number of automatic rescue carbohydrate recommendations(12-hour inpatient study)
- Number of glucagon boluses(12-hour inpatient study)
- Total number of carbohydrates ingested(12-hour inpatient study)
研究者
Jorge Bondia
Jorge Bondia Company
Universitat Politècnica de València